• Regulatory NewsRegulatory News

    EMA Recommends Suspending Medtronic's Inductos Over GMP Issues at CMO

    The European Medicines Agency (EMA) is calling on the European Commission to suspend the marketing authorization for Inductos, Medtronic's implant used to help new bone growth in patients with spinal disc problems and leg fractures. The recommendation comes after a follow up inspection of a US manufacturing site was found to be "non-compliant with manufacturing requirements [and] did not have adequate measures in place to prevent particle contamination." While EMA notes...
  • Regulatory NewsRegulatory News

    EMA to Review InductOs After US Manufacturer Cited for Contamination Issues

    The European Medicines Agency (EMA) has announced it is conducting a review of Medtronic's implantable bone-development product, InductOs, after Spanish and Dutch inspectors discovered contamination issues at a US manufacturing site which makes one of its components. Background InductOs was authorized via the centralized procedure in 2002 and is marketed by Medtronic BioPharma B.V., headquartered in the Netherlands. InductOs is used to promote bone development in pati...